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MHRA approves Moderna Covid vaccine for 12-17-year-olds

MHRA approves Moderna Covid vaccine for 12-17-year-olds

The Moderna Covid vaccine has been authorised for use in 12-17-year-olds, with the MHRA saying yesterday that it is ‘safe and effective’ in this age group.

The vaccine has been approved for use in Great Britain only via the European Commission (EC) Decision Reliance Route, under a conditional marketing authorisation (CMA) extension.

No new side effects were found, and the safety data was similar to that seen in young adults. Most reactions to the vaccine in young adults were ‘mild to moderate’ and occurred in the form of ‘a sore arm or tiredness’. The MHRA expects the majority of side effects in 12-17-year-olds to be no worse than this.

MHRA chief executive Dr June Raine said: ‘We have in place a comprehensive safety surveillance strategy for monitoring the safety of all UK-approved Covid-19 vaccines and this surveillance will include the 12-to 17-year age group.’

The JCVI will now decide whether the age group will be vaccinated with the Moderna as part of the vaccination campaign.

‘It is for the JCVI to advise on whether this age group should be vaccinated with the Covid-19 vaccine made by Moderna as part of the deployment programme,’ Dr Raine said.

It comes as the health secretary this week set a target for all 16-17-year-olds to be vaccinated by Monday 23 August, in time to build immunity before they return to school in September.

The Moderna vaccination was also given the go ahead in Northern Ireland, under the CMA extension granted by the European Medicines Agency (EMA). It is already authorised for adults over the age of 18 in Great Britain.

Earlier this month, trial results showed that Moderna’s Covid-19 vaccine was found to be 93% effective six months after the second dose is given.

After an ‘extremely rare’ blood clot risk was established with the AstraZeneca jab in April, the JCVI recommended that alternative Covid vaccines should be offered to under-30s instead of the AstraZeneca jab.


          

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